Hemorrhoidal diseases include hemorrhoids, anal fissure and the like, and there have been conventionally marketed various preparations in diverse preparation forms, such as oral preparations and recto-anal preparations (e.g., suppository and ointment). Oral preparations intend to smooth dejection and alleviate congestion, bleeding, swelling and pain at the lesion.
In an attempt to give effects by direct application to the lesion, recto-anal preparations, such as suppositories and ointments, are used for decreasing pain, itchness, swelling, inflammation and bleeding at the lesion.
The pharmacological actions required of a therapeutic agent for hemorrhoidal diseases include the following actions on hemorrhoidal diseases, in other words, on the recto-anal region. They are antiedemic action, wound healing accelerating action, mucosal ulcer and inflammatory region healing action and microcirculation disorder improving action. The steroidal antiinflammatory agents generally used as therapeutic agents for hemorrhoids, such as hydrocortisone caproate and diflucortolon valerate, are superior in antiedemic action, whereas they retard wound healing in hemorrhoidal diseases. Moreover, a long-term, consecutive use of steroidal antiinflammatory agents or a use thereof in large amounts for the treatment of hemorrhoidal diseases results in various side effects such as hypersensitivity, irritation, degradation of adrenal and pituitary function, immunosuppression, retardation of systemic wound healing, increase of intraocular pressure and glaucoma. Accordingly, administration of steroidal antiinflammatory agents requires careful observation of the patients' conditions.
In view of the situation as described, a non-steroidal therapeutic agent for hemorrhoidal diseases, which is free of the above-mentioned problems and has antiedemic action, as well as wound healing accelerating action in hemorrhoidal diseases, has been studied for development.